Home GUDID 04042409259043 NA
Primary DI 04042409259043
Brand NA
Company aap Implantate AG
Model IU 7058-22-1U
Device description Drill CS 5.8, ø4.3, L 220, I-ø 2.2, Hudson, single use
Published 2018-02-28
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HTW BIT, DRILL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04042409259043 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04042409259043 04042409259043 4042409259043
GMDN Terms# Term, Definition table Term Definition Cannulated surgical drill bit, single-use A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 328420633 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B803SYN31005100 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310230 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310650 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310660 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310670 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310680 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 00190776403270 Millennium Avalign Technologies, Inc. HTW 2026-07-21 08059386748688 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2026-07-21 B504OM19S17050 Brasseler Provision HTW 2026-07-20 B504OM3162880 Synthes Provision HTW 2026-07-20 B504OM4058830 Biomet Provision HTW 2026-07-20 B504OM4058890 Biomet Provision HTW 2026-07-20 B504OM542022S0 Stryker Provision HTW 2026-07-20 B504OM7024470 Stryker Provision HTW 2026-07-20 B504OMA37330 Medartis Provision HTW 2026-07-20 B504OMAR1214L0 Arthrex Provision HTW 2026-07-20 B504OMAR1217L0 Arthrex Provision HTW 2026-07-20 B504OMCSS07247SQ0 Wright Provision HTW 2026-07-20 B504OMKM166310260 Brasseler Provision HTW 2026-07-20 B504OMKM166310680 Brasseler Provision HTW 2026-07-20 00190776400552 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776400576 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776400644 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776402075 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776402082 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776402204 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776400293 Millennium Avalign Technologies, Inc. HTW 2026-07-17 18257200076536 CETRA Orthofix US LLC HTW 2026-07-17 18257200076574 CETRA Orthofix US LLC HTW 2026-07-17 18257200131211 Firebird SI Fusion Orthofix US LLC HTW 2026-07-17